Open to opportunities

Sadhana Annapragada

@sadhanaannapragada

Clinical Research Coordinator coordinating multi-site Phase II/III trials with inspection-ready TMF, CTMS, and regulatory operations.

United States

Message

What I'm looking for

I’m looking to keep supporting compliant, inspection-ready clinical trial execution—owning TMF/eTMF, regulatory documentation, and site/monitor workflow across multi-site studies.

I coordinate day-to-day operations across 13 active Phase II and Phase III protocols at Alcanza Clinical Research, overseeing regulatory documentation, site communications, monitoring visit preparation, and trial execution.

I maintain inspection-ready Trial Master Files (TMF), CTMS records, and regulatory binders while supporting sponsor monitoring through source review, query resolution, and essential document checks aligned with ICH-GCP, FDA regulations, and sponsor SOPs.

Experience

Work history, roles, and key accomplishments

Current

Clinical Research Coordinator

Current

Alcanza Clinical Research

Feb 2026 - Present (6 months)

Coordinated day-to-day clinical trial operations across 13 active Phase II and Phase III protocols, managing TMF, CTMS, and regulatory documentation with zero major findings during monitoring visits.

Clinical Trial Operations TMF Management CTMS Regulatory Documentation Monitoring Visits ICH GCP

Research Assistant, Biostatistics Department

Boston University School of Public Health

Sep 2024 - Jan 2026 (1 year 4 months)

Supported multi-site clinical research operations through essential document review, regulatory tracking, TMF maintenance, and data quality checks to ensure audit readiness.

Clinical Research TMF Data Quality ICH GCP

Graduate Research Assistant

Boston University School of Dental Medicine

May 2025 - Sep 2025 (4 months)

Prepared and managed regulatory documentation including protocol amendments, continuing review submissions, and informed consent documents to support IRB compliance.

Regulatory Documentation